Key Pharmaceutical Policy Case

In 1999, 19-year-old Abigail Burroughs was diagnosed with cancer of the head and neck.
After chemotherapy and radiation failed to help, Burroughs tried to enroll in a clinical
trial of a new drug treatment, but she didn’t meet the inclusion criteria. She died
on June 9, 2001. Shortly afterward, her father founded The Abigail Alliance for Better
Access to Developmental Drugs, and in partnership with the Washington Legal Foundation,
the alliance submitted a citizen’s petition to the Food and Drug Administration requesting
broader availability of investigational drugs for terminally ill patients.

At issue, says SPH Professor Peter Jacobson, who directs the school’s Center for Law, Ethics, and Health, is the FDA’s drug-approval process, which some say is too lax and others blame for
blocking patients from potentially lifesaving drugs.

Last year, the U.S. Court of Appeals for the District of Columbia decided in the case
of Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach that terminally ill patients have a constitutional right to purchase unapproved drugs
that have successfully completed phase 1 testing. Realizing what was at stake, the
FDA sought a rehearing before the full D.C. Circuit Court of Appeals. That hearing
took place on March 1, 2007, and a ruling is expected soon. The full court’s decision
will have broad public policy and clinical implications, says Jacobson, and the case,
which raises pivotal questions about issues such as drug safety and the medical care
of terminally ill patients, may reach the Supreme Court. Its outcome could reshape
the regulation and sale of pharmaceuticals in this country.

Jacobson coauthored a commentary on the case in the January 10, 2007, issue of the
Journal of the American Medical Association.

He has also coauthored a new book, False Hope: Bone Marrow Transplantation for Breast Cancer (Oxford, 2007), an examination of a new cancer therapy—high-dose chemotherapy with
autologous bone-marrow transplantation—that offered early promise in the late 1980s
but eventually failed. By the time the public understood its shortcomings, more than
30,000 women had received the treatment, which shortened their lives and added to
their suffering. Jacobson says the debacle “exposed the shortcomings of how new clinical
procedures are monitored in this country.”

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At issue: the FDA’s drug-approval process, which some say is too lax and others blame
for blocking patients from potentially lifesaving drugs.